Thursday, June 12, 2025

Teva 'Well Positioned for Upside from Here,' Says JPMorgan

(6/12, The Fly) ...Looking into 2027 and beyond, JPMorgan sees a "long runway for growth," driven by Teva's branded pharma business, which it says includes several multi-billion assets including Austedo, olanzapine, and Duvakitug. With the shares trading at less than 7-times estimated 2025 earnings, and increasing capital allocation flexibility, Teva "appears well positioned for upside from here," says JPMorgan... Full

Trump's Drug Pricing Order Threatens Investment, Says Roche CEO

(6/11, Jared S. Hopkins, The Wall Street Journal) ...The Swiss company has planned to invest $50 billion the the U.S. over the next five years...When asked how Trump's order, signed last month and opposed by the industry, could affect such plans, Chief Executive Thomas Schinecker said Roche was in discussion with the government. "These kinds of investments, you can only make if you can afford those investments. If you cut into that significantly, then the whole industry wouldn't be able to invest these kinds of monies," Schinecker said at the WSJ CEO Council. He said there are other ways Washington can help lower drug costs without "breaking the innovation ecosystem of the U.S."... Sub. Req’d

Braced for Details On Trump's ‘Most Favored Nation' Policy, Pharma Industry is Still Waiting

(6/11, Daniel Payne and Elaine Chen, STAT+) ...Asked when the "price targets" would be issued, a White House spokesperson told STAT in an email that they already had been. Asked when, the spokesperson shared a link to a May 20 announcement in which the administration outlined how it would implement its "most favored nation" policy - but did not set specific price targets. "Nothing more from us at the moment," the White House spokesperson said. The Department of Health and Human Services did not respond to requests for comment... Sub. Req’d

Trump Officials Seek Price Details and Weigh Consumer Sales as They Examine Most Favored Nation Plan

(6/11, Drew Armstrong and Max Bayer, Endpoints News) ...The people who described the sessions spoke on condition of anonymity to describe the private sessions. The White House has been particularly interested in what these companies charge outside the US, on a drug-by-drug, country-by-country basis — information that several pharmas told Endpoints News that they were unwilling to provide... Sub. Req’d

US Chamber Makes Case to Revive Drug Price Suit at Sixth Circuit

(6/11, Nyah Phengsitthy, Bloomberg Law) ...The US Chamber of Commerce and affiliates sought to convince a three-judge appellate panel that it can challenge a Biden-era drug price program after a lower court ruled it lacked proper venue and associational standing to bring the suit...The business groups on Wednesday defended associational standing and identified drugmaker AbbVie Inc. as one its members to be harmed by the program. AbbVie's cancer treatment Imbruvica was one of the 10 drugs selected for the first negotiation cycle... Sub. Req’d

Trump's HHS Urges Against Reviving Chamber of Commerce's IRA Lawsuit

(6/11, Nicole DeFeudis, Endpoints News) ...At the heart of the case is whether the chambers of commerce have standing to challenge Medicare negotiations in an Ohio federal court on behalf of members they say would be "adversely affected" by the program. Allowing the case to move forward could "open the flood gates" to similar lawsuits from businesses and organizations that have "no apparent ties" to the region, Maxwell Baldi, an attorney for the Department of Health and Human Services, told a panel of judges... Sub. Req’d

Federal Officials Schedule Three Listening Sessions this Summer to Address Drug Competition

(6/11, Max Bayer, Endpoints News) ...The first event, slated for June 30, will focus on the generics and biosimilars market. Then, at the July 24 event, the discussion will center on formularies and benefits. A final session on Aug. 4 is called "Turning Insights into Action to Reduce Drug Prices." Though the FTC and DOJ are spearheading the meetings, the announcement on Wednesday also mentioned that HHS and the Department of Commerce will be involved... Sub. Req’d

Cassidy is Circulating a Proposed Law to Push Down U.S. Drug Prices, Backing a Key Trump Ambition

(6/11, John Wilkerson, STAT+) ...STAT viewed a draft of legislation to link U.S. drug prices to those in other countries that two people familiar with the discussions said Cassidy has floated to industry lobbyists. However, one drug industry source said that bill is an old version, and it's not clear how it may have changed. The people asked not to be identified to describe private conversations... Sub. Req’d

How Will Tariffs Affect Prescription Drugs? Get Ready for Price Increases

(6/11, Richard Payerchin, Medical Economics) ..."U.S. Drug Supply Chain, Tariffs, and the Impact on Prices and Availability" was a webinar hosted by the Johns Hopkins Bloomberg School of Public Health. Professors Mariana Socal, MD, PhD, and Jeromie M. Ballreich, PhD, MHS, explained the recent history and current questions about the pharmaceutical industry and what tariffs could mean for physicians and patients... Full

Kennedy's Ouster of US Vaccine Advisors Puts Pharma Ties Under Scrutiny

(6/12, Chad Terhune, Reuters) ...Kennedy said most vaccine experts on the 17-member Advisory Committee on Immunization Practices (ACIP) have received "substantial funding" from drugmakers. He did not provide examples of conflicts of interest for any individual adviser or say how that may have influenced specific recommendations..."To determine that the whole (advisory board), all 17 members, have conflicts of interest, that has not been shown by the evidence," fired board member Dr. Oliver Brooks told Reuters. "However, the decisions that have been made (by Kennedy) undermine confidence in the process and in vaccines."... Full

House Appropriators Call for FDA Tweaks On Accelerated Approvals, Biosimilars

(6/11, Zachary Brennan, Endpoints News) ...On expanding access to biosimilars, House appropriators want the FDA to ensure a shared REMS system for biosimilars and their reference biologics, "based on the risk messaging and profile that encourages cooperation among the REMS participants, while allowing adequate flexibility for REMS with different, but comparable elements, if appropriate." Such a change "may drive increased biosimilar development, expanded patient access, and provide savings," they wrote... Sub. Req’d

FDA Aims for 'Rapid or Instant' Drug Reviews, With AI Tool Initially Assessing Applications

(6/11, Darren Incorvaia, Fierce Biotech) ...The Food and Drug Administration has gone all in on AI since Martin Makary, M.D., took over the agency, most recently demonstrated by the coronation of new generative AI tool Elsa. Now, Makary and Vinay Prasad, M.D., director of the FDA's Center for Biologics Evaluation and Research, have published an outline of the FDA's priorities that includes speedier drug reviews powered by AI document evaluation... Full

US FDA's Rising First-Cycle Complete Response Rate Draws Congress' Attention

(6/11, Sue Sutter, Pink Sheet) ...The House Appropriations Committee's FY 2026 FDA funding bill includes report language requesting an analysis of the recent increase in complete response letters. Continued modernization of cell/gene therapy approval pathways and a crackdown on counterfeit GLP-1 agonist products also are requested. The report includes numerous directives that were in the FY 2025 funding bill, such as a request for clarification that survival data can be used to support accelerated approval for neurological diseases... Global Sub. Full

Reynolds Makes ‘Difficult Decision' to Sign Bill On Pharmacy Benefit Managers

(6/11, Clark Kauffman, Iowa Capital Dispatch) ...Calling it a "difficult decision," Gov. Kim Reynolds signed legislation Wednesday that's intended to help keep rural pharmacies in business but could also lead to higher drug costs for Iowans... Full

Marylanders May See Drug Price Increases from Trump Tariffs

(6/11, Scott Maucione, WYPR) ...Marylanders could see increased insurance premiums, drug prices or problems getting generic drugs if the Trump administration moves forward with planned tariffs, according to experts from the Johns Hopkins Bloomberg School of Public Health... Full

Louisiana Pharmacy Bill Stirs Fierce Debate, Prompts CVS Texts Warning of Closures

(6/11, Alyse Pfeil, Matthew Albright and Meghan Friedmann, The Shreveport-Bossier City Advocate) ...House Bill 358 surfaced Wednesday afternoon from a conference committee with a major new addition: It would ban pharmacy benefit managers from owning pharmacies...But CVS, which owns both a pharmacy benefits manager and a chain of drugstores, said the bill would force them to close 119 Louisiana pharmacies, affecting 1 million patients across the state and 22,000 patients who receive high-cost specialty drugs that smaller pharmacies could find difficult to handle... Full

CVS Responds to Sanders' Op-ed On Pharmacy Middlemen, Says State is ‘Choosing Winners and Losers'

(6/11, Neal Earley, Arkansas Democrat Gazette) ...CVS continued its campaign against new Arkansas legislation regulating pharmacy middlemen, responding directly to an opinion piece Gov. Sarah Huckabee Sanders authored in the New York Times on Tuesday. The retail pharmacy chain has lobbied hard against Act 624 -- legislation Sanders signed into law in April banning pharmacy benefit managers from also having a pharmacy license in the state... Full

Stelara Biosimilar Sees Stada's Specialty Sales Start Strong In Q1

(6/11, Dave Wallace, Generics Bulletin) ...Stada's launch last year of its Alvotech-partnered Uzpruvo (ustekinumab) biosimilar rival to Stelara has helped boost the firm's Specialty sales by 22% in Q1... Global Sub. Full

Formycon Snatches First Brazilian Approval For Lucentis Biosimilar

(6/11, Urte Fultinaviciute, Generics Bulletin) ...Formycon obtained approval for Brazil's first ranibizumab biosimilar, with launch expected in the fourth quarter of 2025. More approvals are anticipated over the next couple of years, as the firm gears up for phased market rollout across the Latin American region. Ranivisio is expected to be a "good contributor" in the near term, as the biosimilar's sales were paused in the US due to pricing pressures... Global Sub. Full

Celltrion's Rituxan Biosimilar Wins Rare Disease Nod as Pfizer, Amgen Land Same-Day OKs

(6/12, Kim Ji-hye, Korea Biomedical Review) ...On Wednesday U.S. time, the FDA approved Truxima for use in moderate to severe pemphigus vulgaris (PV), a rare autoimmune blistering disease, granting the Korean biosimilar maker its fifth adult indication for the CD20-targeting therapy...But Celltrion wasn't the only winner. Pfizer and Amgen also scored approvals the same day for their Rituxan biosimilars, Ruxience and Riabni, respectively, in the PV indication... Full

Biogen Outlines Phase III Ambitions for Felzartamab in Pipeline Push

(6/12, The Pharma Letter) ...Biogen (Nasdaq: BIIB) has highlighted the growing role of felzartamab in its pipeline during a virtual investor seminar, spotlighting three late-stage studies focused on rare kidney diseases and a broader strategy to expand into immune-mediated conditions... Sub. Req’d

European Data Confirms Real-World Benefits of Adalimumab Biosimilars

(6/11, Skylar Jeremias, The Center for Biosimilars) ...In response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and the UK offer compelling insights into the practical benefits of ABP 501 (Amgevita/Amjevita), a leading adalimumab biosimilar... Full

MSN Slams Novartis' Latest Bid to Stall Launch of Entresto Copy

(6/11, Christopher Yasiejko, Bloomberg Law) ..."Novartis has endless resources to spend," MSN said Tuesday, yet expects a rushed rebuttal complete with competing economic analysis. It also said it would show why the alleged harm isn't irreparable and pointed out that courts in Delaware, New Jersey, and Washington, D.C., had all rejected similar arguments by Novartis... Sub. Req’d

Have Sky-High Sales Projections Set the Obesity Market Up to Fail?

(6/11, Elizabeth Cairns and Kyle LaHucik, Endpoints News) ..."Now that Novo and Lilly have paved the way, both in terms of development and commercially, there's a lot of investment. But what that means is every major pharma will want to actually be part of this story, and we are seeing a number of big players making those moves already in the last year, year and a half," said Tapan Maniar, chief business officer of obesity biotech Verdiva Bio, which emerged with $411 million in January. But Powell was skeptical that many more products need to launch, and he cited a different widely-used drug class — statins — as a proxy. "With the statins … you must have had about seven or eight, and they all grew to be big products. Once you get past that number … the market pricing gets more greatly impacted," he said... Sub. Req’d

Markus Sieger Takes the Helm as President Ad Interim at Medicines for Europe

(6/12, Medicines for Europe) ...Markus Sieger, CEO of Polpharma, has taken the position of President ad interim at Medicines for Europe, with immediate effect. The change follows Markus' tenure as Vice President and the departure of Stephan Eder as President of the association... Full

Pharmas to Face Higher Drug Rebates in UK Despite Government's Tweak to Proposal

(6/11, Angus Liu, Fierce Pharma) ...Despite an outcry from the biopharmaceutical industry, the U.K. government has kept the rebate rate under a national drug-cost scheme at a higher level compared with previous years. Following a public comment period, the U.K. government has decided that drugmakers who participate in the statutory scheme must pay a 31.3% rebate on sales of branded medicines in the second half of 2025... Full

Argentina Speeds Up Market Access Process

(6/11, Francesca Bruce, Pink Sheet) ...ANMAT, Argentina's medicines regulator, has cut the time it takes to conduct the first batch evaluation process that must be completed before medicines can be released for sale. The move is expected to reduce the time it takes to get medicines to patients, according to the regulator... Global Sub. Full

Note: Article links may expire over time or require a free registration. All news articles are the property of their respective publishers and copyright holders. [contextual emphasis added].

Teva global subscription access: registration is required to access FirstWord Pharma+ News and The Generics Bulletin. Please note you must be on the Teva Network (in a Teva location or connected via VPN) to access Teva's InfoNOW news resources. If you have any questions or issues, please email InfoNOW@tevapharm.com.

 

•      FirstWord Pharma+ News registration: first-time users, register here with your Teva email address. You will automatically receive a daily FirstWord Pharma+ newsletter; click on any news item to access your account.

•      Generics Bulletin, Pink Sheet, Scrip (Citeline) registration: go to the Generics Bulletin site and choose "Sign In" in the upper right-hand corner. First-time users, choose "Sign Up Here" and enter your Teva email address.